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NCT00086996 · ClinicalTrials.gov registry record · Phase 2
S0356 Oxaliplatin, 5-FU, Radiation Therapy (RT), Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal (GE) Junction
A Phase 2 study of Esophageal Cancer, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 2
- Development phase
- 98
- Enrollment target
- 20
- Study locations
NCT00086996: Completed Phase 2 study of Esophageal Cancer, sponsored by SWOG Cancer Research Network.
NCT00086996 is a Phase 2 study of Esophageal Cancer that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 98 participants, below the 498-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (80% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00086996, a Phase 2 study of Esophageal Cancer, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 98 participants
- Enrollment target
- 20
- Study locations
Study Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and fluorouracil may make tumor cells more sensitive to radiation therapy and may kill more tumor cells. Giving chemotherapy and radiation therapy before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well giving oxaliplatin together with fluorouracil and radiation therapy works in treating patients who are undergoing surgery for stage II or stage III cancer of the esophagus or gastroesophageal junction.
Primary Outcome
Complete pathologic response assessed after chemoradiotherapy and surgery, defined as no evidence of residual disease on path review. Patients who did not receive surgery are assumed to have not responded.
Conditions Studied
Interventions
- DRUG oxaliplatin
- DRUG fluorouracil
- PROCEDURE conventional surgery
- RADIATION radiation therapy
Study Locations (20)
California
- East Bay Radiation Oncology Center - Castro Valley
- Eden Medical Center - Castro Valley
- Valley Medical Oncology Consultants - Castro Valley - Castro Valley
- Valley Medical Oncology - Fremont
- USC/Norris Comprehensive Cancer Center and Hospital - Los Angeles
- Highland General Hospital - Oakland
- Alta Bates Summit Medical Center - Summit Campus - Oakland
- Bay Area Breast Surgeons, Incorporated - Oakland
- CCOP - Bay Area Tumor Institute - Oakland
- Larry G Strieff MD Medical Corporation - Oakland
- Tom K Lee, Incorporated - Oakland
- Desert Regional Medical Center Comprehensive Cancer Center - Palm Springs
- Valley Care Medical Center - Pleasanton
- Valley Medical Oncology Consultants - Pleasanton - Pleasanton
- University of California Davis Cancer Center - Sacramento
- Doctors Medical Center - San Pablo Campus - San Pablo
Alabama
- Mobile Infirmary Medical Center - Mobile
Alaska
- Providence Cancer Center - Anchorage
Arkansas
- Highlands Oncology Group - Springdale - Bentonville
Colorado
- Poudre Valley Hospital - Fort Collins
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2004-09 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
What the finished NCT00086996 record still lists
NCT00086996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 498-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Esophageal Cancer appearing as the primary indexed condition, and to 4 interventions - of which oxaliplatin is the first listed.
NCT00086996 names 20 study sites across 5 states, led by California, Alabama, Alaska.
Frequently Asked Questions
What is clinical trial NCT00086996 about?
NCT00086996 is a clinical study titled "S0356 Oxaliplatin, 5-FU, Radiation Therapy (RT), Surgery for Pts With Stage II or III Cancer of Esophagus or Gastroesophageal (GE) Junction". RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Oxaliplatin and fluorouracil may make tumor cells more sensitive to radi...
What is the current status of trial NCT00086996?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 98 participants. The study started on 2004-09. Estimated completion is 2011-08.
What conditions does trial NCT00086996 study?
This clinical trial studies the following conditions: Esophageal Cancer.
What interventions are being tested in trial NCT00086996?
The interventions under investigation include: oxaliplatin (DRUG), fluorouracil (DRUG), conventional surgery (PROCEDURE), radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT00086996?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00086996 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Esophageal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00086996's enrollment target sits among peer trials
98 56th of 123 higher than 67 of 123 other Esophageal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Esophageal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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